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Genezen · 17 hours ago

Microbiology Technician III

Indianapolis, IN

Full-time

Onsite

Senior Level

5+ years exp

Genezen is a rapidly growing company in the field of gene therapy, dedicated to providing process development and GMP viral vector production. The Microbiology Technician III will oversee environmental monitoring and microbiological testing, ensuring compliance with quality standards and driving continuous improvement initiatives.

BiotechnologyGeneticsManufacturing

No H1B

Responsibilities

Oversees and performs routine and non‑routine EM (viable air, surface, non‑viable particulates) with a high level of independence and technical accuracy

Interprets EM data trends; identifies adverse trends and contamination risks; initiates and drives improvement actions

Leads EM qualification activities and the development of new EM sampling locations, frequencies, and sampling strategies

Serves as SME for Environmental Monitoring, aseptic practices, and contamination control principles

Authors, reviews, and revises SOPs, protocols, and technical reports with minimal oversight

Leads or provides high‑level support to investigations (EM excursions, OOS, atypical results), including root‑cause analysis and CAPA creation

Supports audit readiness and may represent QC Microbiology during internal/external audits (e.g., FDA, clients)

Supports Change Controls, CAPAs, Deviations, and associated documentation to ensure timely, compliant closure

Ensures adherence to aseptic technique, gowning, and environmental controls; provides coaching and corrective guidance when deviations are observed

Supports contamination prevention initiatives and partners with Manufacturing, Facilities, and QA to implement improvements

Trains new personnel on EM, microbiological assays, aseptic technique, and gowning

Serves as a technical resource for troubleshooting laboratory and EM issues

Participates in cross‑functional project teams including manufacturing support, quality initiatives, and facility expansion/qualification activities

Prepares and presents EM and microbiological data summaries to management and cross-functional teams

Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the QC functional area

Adaptability required as work schedule may change based on business needs

Other duties as assigned

Qualification

Microbiology expertiseEnvironmental MonitoringAseptic techniqueGMP complianceData interpretationTechnical writingMentoringCollaborationProblem solving

Required

B.S. degree in a scientific/technical discipline

5+ years of relevant industry experience in laboratory or clean room environment

Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential

Strong expertise in microbiology, cleanroom behavior, EM programs, aseptic technique, and GMP expectations

Ability to independently interpret complex data sets and make science- and risk‑based decisions

Strong technical writing skills (SOPs, protocols, investigations, justification documents)

Ability to lead without authority and mentor junior staff